This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer.

If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy will result in a lower percentage of postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).

Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]

The primary outcome of this study is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications (MCDC)

Secondary Outcome Measures:

Individual components of the primary endpoint (major and minor complications) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]

(In hospital) Mortality within 30 and 60 days [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 60 days ] [ Designated as safety issue: Yes ]

(In hospital) mortality and mortality within 30 and 60 days will be reported. The cause of death and the results of the autopsy report will be noted.

R0 resections (%) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]

The pathological analysis will be finished within 2 weeks.

Operation related events [ Time Frame: Day of surgery, up to 24 hours after surgery. ] [ Designated as safety issue: Yes ]

Operation time is defined as time from incision until closure (minutes) for both the thoracic and the abdominal phase of the procedure. For the robotic procedure, set up time will be recorded separately. Unexpected events and complications occurring during the operation will be recorded (e.g. massive hemorrhage, perforation of other organs).

Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has to be explained (absolute numbers/percentage).

Postoperative recovery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]

Pain: Type and dose of used analgesics will be noted during the hospital admission period.

Visual Analogue Scale (VAS) for pain will be noted at following times: pre-operatively and the first 10 days after surgery and a fixed periods during follow up (6 weeks, 6 months and yearly post-operatively up to 5 years).

Oncologic outcomes [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery. ] [ Designated as safety issue: Yes ]

2, 3 and 5 year disease free and overall survival

Quality of life [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery. ] [ Designated as safety issue: No ]

Rationale: As stated in the 2010 revised Dutch esophageal carcinoma guidelines, the golden standard for surgical treatment of esophageal carcinoma is open transthoracic esophagectomy. Recent evidence suggests that robot-assisted thoraco-laparoscopic esophagectomy using the Da Vinci ® robot can provide an extensive resection, with possibly better or at least equal radical (R0) resection rates and an equal number of dissected lymph nodes. This is accompanied with markedly reduced blood loss and reduction of overall complications with shorter intensive care unit (ICU) and hospital stay. Therefore, the robot-assisted thoraco-laparoscopic esophagectomy is now at a stage that it should be compared to the current standard of care in a randomized controlled trial.

Objective: Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic esophagectomy as an alternative to open transthoracic esophagectomy as treatment for esophageal cancer.

Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)

Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection)

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01544790